1. Cleaning of Clean- Room Pass Boxes:

(A) Subject:  Procedure for Cleaning of Class- Room Pass Boxes.

(B) Purpose: This procedure is applicable for Cleaning of Clean- Room Pass Boxes used in the formulation plant of pharmaceutical company.

(C) Responsible Persons:

  • For the cleaning of equipment- Production Operator/ Technician.
  • Surety about the Cleanliness of Equipment- Production Operator/ Executive.

(D) Compliance: Production Head and QA Head are required for the compliance of this cleaning procedure.

(E) Procedure:

  • Switch off main power supply of machine.
  1. Keep the Pass Box Exterior and Interior free from dust:
  • Firstly, clean the cabinet; door; door handle; SS Caps and light diffuser by using dry lint free duster.
  • Before starting usage for the first time in a day, clean with 70% Isopropyl Alcohol/ Disinfectant using a non- fiber shedding cloth.
  • Then, Wipe out Cabinet; door; door handle and hinges by using wet lint free duster.
  • Inside cleaning of Clean- Room Pass Boxes is recommended in following cases:
  • Before starting any work in the Pass Box.
  • In the case of liquid spillage in the pass box or whenever required.
  • In the last, Affix “Cleaned” labelled on the Clean- Room Pass Box.
  1. Shutting- Down Procedure:
  • First, disconnect all utilities.
  • Then clean the entire area with 70% Isopropyl Alcohol/ Disinfectant.
  • Then, Record the details of UV burning, differential pressure.

Note: UV light shall be replace after completion of three years or 8000 burning hours whichever is earlier.

  • Expose the plate in the pass box on every working day and record.
  • Perform the revalidation of Clean- Room Pass Boxes on yearly basis.

(F) Distribution:

  • Master Copy- Quality Assurance.
  • Controlled Copies- Quality Control & Assurance and Production.
  1. Monitoring of Clean- Room Pass Boxes:
  2. Transfer the pre- incubated soybean casein digest agar Petri- Plate into the Pass Box (LAL test- room to incubator).
  3. Then, enter the respective pass box clean- room area.
  4. Decontaminate the external surface of the Petri Plates with the help of sterile mop soaked in a filtered sporicidal agent.
  5. Mark the Petri Plates at the base with the following details by using marker:
  • Media Lot Number
  • Name of the location/ ID
  • Date of Exposure
  • Exposed by
  1.  Place the Petri Plates inside the respective clean- room pass box and remove the upper lid of the Petri Plate and keep it in an inverted position.
  2. Expose the media plates for 4 hours. After 4 hours of exposure, close the Petri Plate with lid.
  3. Collect the Petri Plate and then place them into the incubator.
  4. Incubate the exposed Petri Plate in an incubator in an inverted position at 32.5 ± 2.5 °C for 5 days.
  5. After incubation observe the plates for a number of colonies on the colony counter or in the light source by using a marker.
  6. Note down the observation.
  7. If the counts obtained are above the limits specified below, investigate the results and take necessary actions.
  8. Frequency of Monitoring: Class A- Daily.
  9. Acceptance Criteria:
  • Action Limit: Class A- 1 CFU/ Plate.

 

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